There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial

Granulation Method and Process Monitoring Matter

FDA updates guidance to reflect advances in technology.

FDA Reissues Bioanalytical Method Validation Guidance

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

The Importance of Characterization in Biosimilars Development

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

The Basics of Measurement Uncertainty in Pharma Analysis

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

FDA Publishes Draft Questions and Answers to Generic-Drug Stability Testing Guidance

Conventional cell-imaging systems that provide high quality data can be very expensive and complex to use. New systems from Biotek Instruments are designed to overcome these issues.

Making Cell-Imaging Systems More Accessible

A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients.

ICH Guideline for Elemental Impurities Moves to Step 2b

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

Demonstrating Biosimilarity

The authors examine alternative solvents for extractables and leachables screening evaluation of process components that provide extraction equivalence and do not interfere chromatographically.

Alternative Solvents for Extractables and Leachables Evaluation

Editor's Pick's of Pharmaceutical Science & Technology Innovations: The latest in analytical instrumentation including mass spectrometers, calorimeters, and viscometers.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes